Building Genetic Medicine

Prof. Parthasarathy's first book, Building Genetic Medicine, explores the development and implications of genetic testing for breast and ovarian cancer (BRCA testing) in the United States and Great Britain. It explores the international "race" to find the BRCA genes, the early competition among testing providers, the impact of the BRCA gene patents on testing provision and use, the integration of BRCA testing into health care, and the controversies over the BRCA gene patents in the two countries.

This book influenced the AMP v. Myriad court case, which challenged the patentability of human genes. The suit was brought by a coalition of scientists, physicians, and patients, and represented by the American Civil Liberties Union. When the case was at the District Court, Judge Robert Sweet heavily cited Prof. Parthasarathy's expert declaration when he ruled that the BRCA1 gene patent is invalid because the genes are "products of nature." Prof. Parthasarathy's declaration, based on findings from her book, argues that the gene patents were not needed as an incentive to stimulate research, and that the gene patents have had negative implications for researchers, health care professionals, and patients in the United States.

On June 13, 2013, the US Supreme Court largely agreed with the plaintiffs in the case. They decided, unanimously, that isolated human genes are "products of nature" and therefore unpatentable.

BOOK DESCRIPTION

In Building Genetic Medicine, Shobita Parthasarathy shows how, even in an era of globalization, national context is playing an important role in the development and use of genetic technologies. Focusing on the development and deployment of genetic testing for breast and ovarian cancer (known as BRCA testing) in the United States and Britain, Parthasarathy develops a comparative analysis framework in order to investigate how national "toolkits" shape both regulations and the architectures of technologies and uses this framework to assess the implications of new genetic technologies.

BRCA testing was one of the most highly anticipated and publicized technologies of contemporary medicine. Parthasarathy argues that differences in the American and British approaches to health care and commercialization of research led to the establishment of different BRCA services in the two countries. In Britain, the technology was available through the National Health Service as an integrated program of counseling and laboratory analysis, and was viewed as a potentially cost-effective form of preventive care. In the United States,although BRCA testing was initially offered by a number of providers, one company eventually became the sole provider of a test available to consumers on demand.

Parthasarathy also reports on an unsuccessful attempt by the American provider of BRCA testing to market its services in Britain. British scientists, health-care providers, and patients rejected the American technology, she argues, because it was part of a social, economic, and political system to which they were not accustomed. Parthasarathy draws lessons for the future of genetic medicine from these cross-national differences, and discusses the ways in which comparative case studies can inform policy-making efforts in science and technology.

ENDORSEMENTS

"Combining historical, comparative, and coevolutionary perspectives, this book offers a highly original and informative account of the emergence of BRCA testing as a much debated and controversial new health care technology. It makes the reader vividly aware of the various ways in which technologies and practices of health care mutually shape each other."—Dirk Stemerding, Science, Technology, Health & Policy Studies, University of Twente, The Netherlands

"Parthasarathy's book is a beautifully structured, clearly written Tale of Two Cultures. Testing for genes that confer risk of breast cancer was born of Mendelian genetic science and DNA analysis technologies, parentage revered on both sides of the Atlantic. As that genetic testing developed into clinical services, however, it turned out that the story was not just about who discovered what when, or even who owned which patents, but also about how decisions are made about health care technologies, health services, and public health. This story is thus a nonfiction Bildungsroman about a genetic innovation that developed quite differently in the United States and the United Kingdom, two cultures divided by a common science."—Robert Cook-Deegan, Director, Center for Genome Ethics, Law, and Policy, Duke University

"The assumption that universally valid generalizations regarding the value of new medical technologies are possible, given good enough clinical evidence, is proving highly resistant to critique from the social sciences. Shobita Parthasarathy shows how and why genetic testing acquired quite different roles in the United States and in Britain, evoking very different responses from patient advocacy groups in the two countries. Her book is not only a valuable addition to the STS literature. I hope that everyone confronting the implications of rapid scientific and technological advance for health care provision will reflect carefully on what it has to say."—Stuart Blume, Chair, The Innovia Foundation for Medicine, Technology & Society, and Professor of Science Dynamics, University of Amsterdam

REVIEWS"Building Genetic Medicine is an enlightening overview of one of the first skirmishes of our genetic century." --American Scientist

"This well-crafted, interdisciplinary book offers a comparative analysis of how breast cancer genetics has actually played out in the United States and the United Kingdom....While not quite as gripping as a murder mystery, the end result is much more of a page-turner than many, many academic books--especially first books." --Metascience

"Overall this book is very thought provoking and demands readers to consider the directions we want our health systems to go." --European Journal of Human Genetics

"In the end, this insightful book should have wide appeal, and it seems it would be an important read for anyone involved in the "architecture" of genetic medicine." --American Journal of Human Biology.

"Parthasarathy usefully shows how the construction of identities and technologies are shaped by particular social and political environments, and by nationally specific ideas about practitioners and users of health care....The analysis based on the relationship to ideologies of governance is valuable in this context, but could usefully inform a broader understanding of the power cultural specificities have in relation to other aspects of breast cancer too." --Sociology of Health and Illness

"Parthasarathy rightly points to the latest and troubling frontier where the "inscription of national context into technological architectures can create significant challenges for economic globalization" --Bulletin of the History of Medicine.

"As global medicine and technology transfers assume a more prominent position in daily health-policy decisions, the meaningful ideas set forth in this book remind readers to reconsider how medical technology is created, adopted, and defined." --Technology and Culture

"Parthasarathy's valuable analysis illustrates how the BRCA testing systems that developed in the US and the UK each 'defined risk, disease and the treatment options in rather different ways. Her insights into how distinctive national institutions and institutional practices shape policy and practices offer a valuable contribution to both science studies and science policy." --Biosocieties.